BEUDAMED
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    ISA-21 INTERVENTIONAL SPINE ARRAY COIL

    FDA 510(k)
    FDA Class 2 ·Radiology

    REPROCESSED SOFT TISSUE ABLATORS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CORTEX METAMAX

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 24, 2025

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·October 27, 2024

    UNIVERS VAULTLOCK GLENOID REAMER X-LARGE

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code LXH·April 30, 2024

    NANOKNIFE SYSTEM

    FDA Adverse Event
    Injury ·ANGIODYNAMICS·Product code OAB·March 15, 2013

    PRODISC-L IMPLANT POLYETHYLENE INLAY

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code MJO·March 10, 2011

    J-VAC RESERVOIR

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code GCY·March 27, 2008

    CD001, 10MM RETRIEVAL SYSTEM, 10/BX

    FDA Adverse Event
    Malfunction ·APPLIED MEDICAL RESOURCES·Product code GCJ·September 25, 2019

    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014